Metastatic Castration-Resistant Prostate CancerPhase 2NCT01663415
A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study testing Enzalutamide in people with Metastatic Castration-Resistant Prostate Cancer, run by Astellas Pharma Global Development, Inc..
Trial summary
The purpose of this study is to investigate radiographic progression-free survival (PFS) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer
- What is being tested?
- Enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Progressive prostate cancer while on androgen deprivation therapy
- Castrate testosterone level
- Maintenance of surgical or medical castration for duration of study
- Radiographically visible metastatic disease
- Symptomatic from prostate cancer
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectancy >=6 months
Who cannot join
- Brain metastases or leptomeningeal disease
- Prior cytotoxic chemotherapy for prostate cancer
- Prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor
- History of seizure or condition that may predispose to seizure
- History of loss of consciousness or transient ischemic attack within 12 months
- Clinically significant cardiovascular disease
About this study
Official title: A Phase 2, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to investigate radiographic progression-free survival (PFS) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease.
- Being tested
- Enzalutamide
- Keywords
- MDV3100, prostate, cancer, enzalutamide
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called MDV3100
oral
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide | Experimental | Not described Receives: Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic progression free survival (PFS)
Time from first dose on Day 1 to the first objective evidence of radiographic progression or death due to any cause (whichever occurs first). Radiographic disease progression is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Clinical Trials Working Group 2 (PCWG2).
Measured: 26 months
Secondary outcomes (6)
Overall survival
Time from first dose on Day 1 to death due to any cause
Measured: 26 months
Time to PSA progression
Time from first dose on Day 1 to first observation of PSA progression
Measured: 26 months
Change from baseline to last post baseline measurement Quality of life score using Functional Assessment of Cancer Therapy-Prostate (FACT-P)
The FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer patients
Measured: Baseline and 26 months
Change from baseline to last post baseline measurement Quality of Life score using European Quality of Life 5-Domain Scale (EQ-5D)
EQ-5D is a standardized instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status and is designed for self-completion by respondents
Measured: Baseline and 26 months
Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form)
Brief Pain Inventory is a validated instrument that is a subject self-rating scale assessing level of pain, effect of the pain on activities of daily living, and analgesic use
Measured: Baseline and 26 months
Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs)
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Why it stopped: A business decision was made to not initiate this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663415
- Sponsor's protocol ID
- 9785-UC-0001
- Status last verified
- Sep 2012
- First submitted
- 9 Aug 2012
- Last updated
- 17 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01663415
- Acronym / sponsor ID
- 9785-UC-0001
- Keywords
- MDV3100, prostate, cancer, enzalutamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A business decision was made to not initiate this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Study start
- Aug 2012
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate radiographic progression-free survival (PFS) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide | Experimental | Drug: Enzalutamide |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Progressive prostate cancer while on androgen deprivation therapy
- Castrate testosterone level
- Maintenance of surgical or medical castration for duration of study
- Radiographically visible metastatic disease
- Symptomatic from prostate cancer
Key exclusion criteria (6 listed)
- Brain metastases or leptomeningeal disease
- Prior cytotoxic chemotherapy for prostate cancer
- Prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor
- History of seizure or condition that may predispose to seizure
- History of loss of consciousness or transient ischemic attack within 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnzalutamideAlso: MDV3100oral | Drug | Enzalutamide |
Primary outcome
Radiographic progression free survival (PFS)
Time frame: 26 months
Time from first dose on Day 1 to the first objective evidence of radiographic progression or death due to any cause (whichever occurs first). Radiographic disease progression is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Clinical Trials Working Group 2 (PCWG2).
6 secondary outcomes
Overall survival
Time frame: 26 months
Time to PSA progression
Time frame: 26 months
Change from baseline to last post baseline measurement Quality of life score using Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time frame: Baseline and 26 months
Change from baseline to last post baseline measurement Quality of Life score using European Quality of Life 5-Domain Scale (EQ-5D)
Time frame: Baseline and 26 months
Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form)
Time frame: Baseline and 26 months
Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs)
Time frame: 26 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senior Medical Director study director
Astellas Pharma Global Development
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enzalutamide in people with Metastatic Castration-Resistant Prostate Cancer, run by Astellas Pharma Global Development, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic progression free survival (PFS) (time frame: 26 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2012.